Kornimate/medical-research-clean huggingface dataset:
egfr-il12-cart cells for patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this is a clinical study to observe the maximum tolerated dose (mtd) and the safety and feasibility of chimeric antigen receptor egfr (egfr -il12 -cart) cells in metastatic patients with colorectal cancer.

this is a study for the patients with colorectal cancer. maximum tolerated dose climbing test is expected into the group of 9 cases of patients. and phase ii expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. subjects will be collected their t cells and modify them, the modification is a genetic change, that egfr:4-1bb:cd28:cd3 modified t cells, in order to tells the t cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. the cart cells will then be expanded in vitro and then administered to subjects. fourth generation cart, also known as trucks (t cells redirected for universal cytokine before), mainly in order to improve the effect of solid tumor treatment and design, through nfat transcription factors inducing expression of il - 12, overcome the solid tumor within the tumor microenvironment of cart limit the function of cellsthe purpose of this study is observe the mtd and to assess the safety and feasibility of cart cells in the patients with metastatic colorectal cancer.

Eligibility criteria:
inclusion criteria: 1. patients must be 18 years to 70 years; 2. clinical diagnosis of egfr positive for patients with metastatic colorectal cancer; 3. patients must have a kps of \>80, expected survival \> 3 months; 4. patients must have at least one measurable lesions; 5. recently did not use glucocorticoid; 6. patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters: wbc ≥ 3.0×109/l, hb ≥90 g/l, plt ≥100×109/l）; ast ≤2.5uln，alt ≤ 2.5uln; cr≤ 3uln; tbil≤ 3uln， 7. patients must have a good heart function (lvef\>50%) ; 8. patients must be willing to practice birth control during and for three months following treatment.note:female participants of reproductive potential must have a negative serum pregnancy test, and willing to practice birth control during and for three months following treatment； 9. patients must be willing to sign an informed consent. exclusion criteria: 1. patients with other cancer history; 2. patients allergic to cetuximab; 3. patients with severe bronchitis, bronchial asthma, or severs pneumonia; 4. patients with uncontrolled active infections (bacteria, viruses or fungi infection) ; 5. patients with acute and chronic gvhd (graft versus host disease) 6. patients with severe autoimmune diseases; 7. previously treatment with t cell inhibitors (cyclophosphamide, fk506); 8. patients with active hepatitis b or hepatitis c infection, hiv infection, syphilis serology reaction positive; 9. patients who are participating or participated any other clinical research in the past 1 months; 10. pregnant and/or lactating women will be excluded; -
ultra low iodine loaded spectral ct angiography (cta)

Conditions: Peripheral Arterial Disease; Renal Insufficiency

Summary: the objectives of this study are: evaluation of ultra-low iodine load cta protocols of the aorta and lower extremities. to investigate whether dual-layer in combination with with virtual monoenergetic imaging (vmi) allows for reduction of contrast medium (cm) in cta of the aorta and lower limbs i with sustained objective and subjective image quality parameters.

ct angiography (cta) of the aorta and the lower limb is one of the most important tools for diagnostic, evaluation of the severity of the peripheral arterial disease, decision making, treatment planning and follow-up; but usually requires the use of iodine contrast medium. due to the high prevalence of renal impairment (egfr \< 90 ml/min/1.73m) in the elderly hospitalized population (more than 90% among inpatients aged over 60 years) contrast-medium-induced nephropathy is a major concern in this population. the recently introduced spectral ct technique utilizes x-rays covering a spectrum of energy-levels as opposed to conventional ct in which x-rays are set to one specific energy level. this technology offers many possibilities, such as "boosting" the x-ray contrast effect of iodine. this improves the vascular enhancement of the contrast medium using low-energy, virtual monoenergetic imaging (vni). the objectives of this study are: evaluation of ultra-low iodine load cta protocols of the aorta and lower extremities. to investigate whether dual-layer in combination with with virtual monoenergetic imaging (vmi) allows for reduction of contrast medium (cm) in cta of the aorta and lower limbs i with sustained objective and subjective image quality parameters.

Eligibility criteria:
inclusion criteria: * inpatients and outpatients with kidney function (egfr) allowing for safe administration of standard contrast dose (as calculated with the omnivis calculator). * patients with clinical suspicion of disease of the aorta and/or arteries in the lower limb. * referral to cta diagnosis, treatment planning or follow-up. exclusion criteria: * iodine contrast medium allergy * age \< 18 years * lack of informed consent * critical ischemia of the lower extremities

Keywords: computed tomography angiography contrast media
comparing robotics and laparoscopy with laparotomy/open surgery for endometrial cancer

Conditions: Cancer of the Endometrium

Summary: the use of robotic surgery in the management of gynecologic cancers has increased exponentially in the united states since the implementation of technology in 2005. in canada, access to the system is limited because of a lack of government funding. the government has been reluctant to fund this technology because robust data, on the true impact to patient care, is lacking. this project will prospectively examine outcomes of women, with early stage endometrial cancer, treated surgically. open surgery will be compared to minimally invasive surgery (mis) which will include conventional laparoscopy and robotic surgery. the data collected will include detailed assessment of surgical data, peri-operative events, quality of life analysis, health economic evaluation and evaluation of mis rates.


Eligibility criteria:
inclusion criteria: * any type of histologically confirmed early stage (stage 1 or 2) cancer of the endometrium * ecog performance status of 0-1 * suitable candidate for surgery * signed approved informed consent * female, 18 years of age or older * pre-operative health is graded as asa i-iii * patients able to complete baseline questions either on their own or with assistance * patient willing to comply with scheduled visits exclusion criteria: * major abdominal surgery, chemotherapy or radiation within 3 months before the baseline visit * evidence of diffuse peritoneal carcinomatosis by imaging or clinical exam * unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator) * patients who are breastfeeding or become pregnant during the study

Keywords: laparotomy open surgery laparoscopy robotic surgery
the association between fatty liver (nafld) disease and pcos

Conditions: Polycystic Ovarian Syndrome,; Nonalcoholic Fatty Liver Disease

Summary: since both pathologies (pcos and nafld) involve disturbed carbohydrate economy, which revolve around insulin resistance, it is tempting to examine the specific "liver profile" of women with pcod. furthermore, it would be of great importance if lean women who suffer from pcod would be revealed to shere cardiovascular risks with their more overweight peers. patients - women who will be diagnosed with pcod following their initial referal to our fertility clinic. controls - normal ovulatory women who approached our fertility clinic due to either unexplained or male factor infertility. workup - history for menstrual pattern; clinical evaluation for features of hyperandrogenism; ultrasonographic documentation of ovarian morphology; follicular phase hormonal profile for validation of the diagnosis and for ruling out other pathologies which may cause anovulation. liver profiling - the following blood tests will be used for the biochemical profiling: fasting glucose and insulin, crp, hdl-cholesterol, triglycerides, ast, alt, ggt, ldh, alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, hba1c and micro albumin ratio. fibroscan® will be used to measure liver stiffness.


Eligibility criteria:
workup - history for menstrual pattern; clinical evaluation for features of hyperandrogenism; ultrasonographic documentation of ovarian morphology; follicular phase hormonal profile for validation of the diagnosis and for ruling out other pathologies which may cause anovulation. liver profiling - the following blood tests will be used for the biochemical profiling: fasting glucose and insulin, crp, hdl-cholesterol, triglycerides, ast, alt, ggt, ldh, alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, hba1c and micro albumin ratio. fibroscan® will be used to measure liver stiffness, as previously described
novel and scalable internet supplemented weight loss treatment in primary care

Conditions: Overweight; Obesity

Summary: motivational interviewing and nutritional counseling for weight loss in primary care.

overweight and obese participants will be recruited through local primary care offices. this study will test the effectiveness of motivational interviewing and nutritional counseling for weight loss. the treatment will be supplemented by internet support.

Eligibility criteria:
inclusion criteria: * bmi 25-55 * daily access to internet and phone * recruited through local primary care offices. * age 18-65 exclusion criteria: * co-existing physical and/or psychiatric conditions that require more significant treatment (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders) * meets criteria for current substance abuse/dependence * currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating * pregnant, breastfeeding, or plans to become pregnant during the treatment period * cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack * serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function) * uncontrolled diabetes, thyroid conditions, or hypertension
phase ii study of haic using cisplatin,leucovorin and 5-fluorouracil

Conditions: HepatoCellular Carcinoma

Summary: the purpose of this phase ii study is to determine the recommended dose, as well as the safety and efficacy of the combination of oxaliplatin, leucovorin and 5-fu introduced by hepatic arterial infusion chemotherapy (haic) in patients with advanced hepatocellular carcinoma (hcc).

the results of our preliminary pilot study suggested that the combination of oxaliplatin, leucovorin and 5-fu introduced by hepatic arterial infusion chemotherapy (haic) may improve the survivals for advanced stage hcc. thus, the investigators carried out this prospective randomized control study to determine the recommended dose as well as the safety and efficacy.

Eligibility criteria:
inclusion criteria: the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) patients must have at least one tumor lesion that can be accurately measured according to easl criteria. diagnosed with major or main portal vein invasion (vp3 or vp4) kps≥70； with no previous treatment no cirrhosis or cirrhotic status of child-pugh class a only not amendable to surgical resection ,local ablative therapy and any other cured treatment. the following laboratory parameters: platelet count ≥ 75,000/µl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 30 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy known history of hiv history of organ allograft known or suspected allergy to the investigational agents or any agent given in association with this trial. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy evidence of bleeding diathesis. patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. any other hemorrhage/bleeding event \> ctcae grade 3 within 4 weeks of first dose of study drug serious non-healing wound, ulcer, or bone fracture known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma hepatic arterial infusion chemotherapy optimal dose
low intensity shock-wave therapy (li-eswt) in penile rehabilitation after radical prostatectomy

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Summary: erectile dysfunction (ed) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. a few small studies have recently shown that low-intensity shockwave therapy may improve sexual performance in men with ed. however, the optimal dosage and length of treatment is yet to be determined. the investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ed following prostatectomy surgery.

erectile dysfunction (ed) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. at present, this debilitating consequence of surgery is managed in a step-wise approach including oral medication, injections and in severe cases, insertion of a penile prosthesis. a few small studies have shown that low-intensity shockwave therapy may improve sexual performance in men with ed. however, the optimal dosage and length of treatment is yet to be determined. the investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ed following prostatectomy surgery. low-intensity shockwave therapy would be a non-invasive treatment to preserve and improve patient's sexual function.

Eligibility criteria:
inclusion criteria: * age 40 - 65 * diagnosed with low/intermediate-risk prostate cancer: * psa \< 20 ng/ml * gleason score \< 8 * pca stage =\< t2b * baseline iief-ed 17-30 without erectogenic aids * no pre-operative urinary incontinence (no usage of urinary pads) * sexually active * able to understand and complete patient questionnaires * consent to participate exclusion criteria: * anatomical abnormalities in the genitalia or pelvic region * post-rp complications that could impact safety or effectiveness of eswt (eg. hematoma, fistula, unresolved anastomotic leak) * incomplete tumor removal (positive surgical margin) * tumor upstaging beyond t2b * nerve sparing score \> 5 * previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy * untreated hypogonadism (serum total testosterone \< 300 mg/dl) * anti-coagulant medication, except acetylsalicyclic acid up to 100mg daily * any other condition that would prevent the patient from completing the study, as judged by the principle investigator

Keywords: erectile dysfunction shockwave treatment prostatectomy
a study for using radiosurgery on limited metastases

Conditions: Neoplasms, Metastatic

Summary: the standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or hormonal therapy alone or in combination. the main purpose of this study is to evaluate whether radiosurgery alone affects your quality and length of life. a second purpose of this study is to determine if the levels of special types of protein (called cytokines) found in the blood are related to your quality of life during your course of treatment and follow-up.

in this research study high dose stereotactic body radiation therapy will be directed at the site of metastasis. this treatment will be given once a day, 5 times a week (monday through friday) for one to four weeks depending on the location and size of the disease to be treated. blood for the cytokine tests will be drawn before your therapy starts, weekly during therapy and at the follow-up visits as stated in the next paragraphs. two to four tablespoons of blood will be removed each time.

Eligibility criteria:
inclusion criteria: age ≥ 18 years kps ≥ 70 palliative: disease most likely to be life limiting, is definable, and treatable to a sterilizing dose according to protocol criteria. the size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol previously treated lesions are not eligible unless the prescribed dose can be safely delivered. previously enrolled patients can be retreated to new lesions if they still meet protocol requirements. informed consent must be obtained. pregnancy test must be negative for women of child bearing potential. out of state patients are eligible, if communication with the referring physicians is expected to be adequate to address the primary aim. the secondary aim (blood cytokines) is optional for out-of-state patients. exclusion criteria: technical inability to achieve required dose based on safe dose constraints required for radiosurgery women who are pregnant or nursing.. failure to meet inclusion requirements contraindications to radiation. patient should not be eligible for primary disease specific radiosurgical protocols
fertility and the microbiome

Conditions: Subfertility; Asthenozoospermia

Summary: with this study, the investigators want to investigate the microbiome and human papilloma virus (hpv) status of couples with subfertility. the investigators want to gain information about association of female and male microbiome and its impact on fertility. hpv prevalence is high, and its impact on fertility has not been studied intensively. the investigators want to find out whether there is an association between hpv status and subfertility, vaginal and seminal microbiome and hpv status and the prevalence among our subfertile couples. as part of this study, the investigators will perform a randomized placebo controlled double blind pilot study to investigate the association between altered sperm quality (impaired motility and elevated dna fragmentation index), the seminal microbiome and whether intake of probiotics alters these parameters.

observational study: the investigators will include 150 couples within 24 months and will take samples of oral, urinary, stool, vaginal, uterine and seminal microbiome and cervical as well as seminal samples for hpv analysis. further, the investigators will test for other sexually transmittable diseases, hormone status and metabolic status. time to pregnancy, pregnancy rate and live birth rate will be evaluated. placebo controlled double blind randomized controlled trial: 30 subfertile men (asthenozoospermia, elevated dna fragmentation index) will be randomized in to two groups: placebo or probiotics for 3 months daily. before and after these 3 months, sperm count microbiome analysis and hpv analysis will be performed to find possible associations with intake of probiotics.

Eligibility criteria:
inclusion criteria: * couples (males and females) with subfertility, primary or secondary infertility, or recurrent pregnancy loss. exclusion criteria: * unable to consent * diseases or conditions that might impact investigation * intake of probiotics, antibiotics within last 3 months * intake of nutritional supplements * chemo therapy or radiation therapy * excess alcohol intake * smoking
long-term follow-up (ltfu) of subjects treated with ntla 2002

Conditions: Hereditary Angioedema

Summary: this is a follow-up study of subjects who received ntla-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.


Eligibility criteria:
inclusion criteria: 1. a subject has completed or discontinued from an intellia-sponsored or -supported treatment protocol in which a complete or partial dose of ntla-2002 was received. 2. a subject has provided informed consent for the ltfu study. 3. a subject is willing to attend study visits, complete protocol-required follow-up schedule, and comply with the study requirements. exclusion criteria: none
trans-anal eco-doppler evaluation of haemorrhoidal vascularization after percutaneous hemorrhoidal artery embolization. a pilot study.

Conditions: Haemorrhoidal Bleeding

Summary: to evaluate the usefulness of endoanal ultrasound in the evaluation of emorrhoidal artery embolization outcomes

haemorrhoidal artery embolization (emborrhoid) is a novel method for the treatment of haemorrhoids. through the catheterization of the femoral artery and a selective angiogram of the inferior mesenteric artery, embolic agents are delivered to occlude the sra. despite the technical success rate has been reported to reach 93%-100%, clinical success ranges between 63% and 94% with rebleeding occurring in 13.6% of cases due to the presence of a significant mra in 24% of cases \[biblio} . there is no data in the literature on how the arterial flow changes after the treatment. the primary aim of the present study was to assess the reduction in the blood supply by comparing the hemorrhoidal arterial systolic peak before and after hemborrhoid by using endoanal ultrasound (eaus) combined with doppler. the secondary aim was to evaluate if a relation exists between the reduction and the efficacy of this treatment by the hemorrhoidal bleeding score.

Eligibility criteria:
inclusion criteria: * symptomatic hemorrhoidal disease (french bleeding score \[fbs\] \> 4), goligher's classification score ii or iii, age \>18 years, failure of non-operative management (change life style, dietary modification, supplemental fibers for constipation, over-the-counter treatments). exclusion criteria: * age \< 18 years, goligher prolapse score iv, pregnancy, previous haemorrhoidal surgery, inflammatory bowel disease.